CARTO® 3 System and Real Time Intracardiac Ultrasound (NCT01716663) | Clinical Trial Compass
CompletedNot Applicable
CARTO® 3 System and Real Time Intracardiac Ultrasound
United States234 participantsStarted 2012-10
Plain-language summary
This is a prospective, multicenter, non-randomized observational study of subjects 18 years and older undergoing RF ablation with drug refractory recurrent symptomatic paroxysmal Atrial Fibrillation (AF).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Drug refractory, recurrent symptomatic paroxysmal AF
* Age 18 years or older
* Patients able and willing to provide written informed consent to participate in the study and comply with study requirements
Exclusion Criteria:
* Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
* Previous ablation for atrial fibrillation
* AF episodes that last longer than 30 days
* Uncontrolled heart failure, or NYHA Class III or IV heart failure
* Documented intra-atrial thrombus or other abnormality on pre-ablation imaging
* Contraindication to anticoagulation
* Stroke, cardiac surgery, unstable angina, myocardial infarction or percutaneous coronary intervention within the past 3 months
* Awaiting cardiac transplantation
* Heart disease for which corrective surgery is anticipated within 6 months
* Enrollment in other investigational drug or device study
* Subjects unwilling to comply with protocol or follow-up requirements
* Patients who are pregnant